SIR-Spheres for the treatment of cholangiocarcinoma
Research type
Research Study
Full title
A prospective, multicentre, randomised, controlled study evaluating SIR-Spheres Y-90 resin microspheres preceding standard cisplatin-gemcitabine (CIS-GEM) chemotherapy versus CIS-GEM chemotherapy alone as first-line treatment of patients with unresectable intrahepatic cholangiocarcinoma (SIRCCA)
IRAS ID
208636
Contact name
Harpreet Wasan
Contact email
Sponsor organisation
Sirtex Technology Pty Ltd
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
CANC 31007, NIHR CRN reference
Duration of Study in the UK
3 years, 1 months, 12 days
Research summary
Chemotherapy, using a combination of gemcitabine plus cisplatin (CIS-GEM), is the 1st line of standard of care in many countries, for the treatment of ICC. However, this is not a curative approach and surviaval rates remain low. Selective Internal Radiation Therapy (SIRT) using SIR-Spheres Y-90 resin microspheres, is a form of treatment that has been designed to selectively deliver high dose of radiation directly to the tumour cells. SIR-Spheres Y-90 resin microspheres are regulated as a medical device product based on international definition of devices. This treatment has been approved for use in primary liver cancers in many countries, including the UK. In retrospective and prospective cohort studies using SIRT in patients with ICC, the results provide preliminary evidence that SIRT is a safe and effective treatment option for unresectable ICC.
This study will be the first to combine the use of chemotherapy with SIRT in subjects with unresectable ICC. The study is a randomised, controlled study. The control group will receive the current standard of care treatment for unresectable ICC, which is chemotherapy (CIS-GEM). The second group will receive treatment with SIRT, followed by chemotherapy (CIS-GEM) as per standard of care.
The primary objective of the study is to compare survival at 18 months between the two treatment arms (one arm being the control and the other receiving SIRT).
REC name
North East - York Research Ethics Committee
REC reference
17/NE/0036
Date of REC Opinion
13 Feb 2017
REC opinion
Favourable Opinion